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Last Updated: July 5, 2020

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CLINICAL TRIALS PROFILE FOR NIPENT

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505(b)(2) Clinical Trials for Nipent

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT03249831 Non-Myeloablative Conditioning Regimen With Haploidentical T-Cell-Depleted Peripheral Blood Transplant for Patients With Severe Sickle Cell Disease Recruiting City of Hope Medical Center Phase 1 2018-01-01 Stem cells are made in the bone marrow, and can circulate the blood stream. These blood forming stem cells are collected from the blood stream (peripheral blood stem cells) or the bone marrow for transplant. Blood stem cell transplants can be used to treat patients with sickle cell disease. In the future it is hoped that transplants may also be used to treat other health conditions like diabetes and auto-immune disease. Transplant is often not an option for patients with other serious medical problems and most patients do not have a full-matched donor. Improving transplant success and reducing transplanted-related complications (like graft versus host disease) might allow more patients to get a transplant from a half-matched (haploidentical) donor (e.g. parent, sibling, and daughter/son). This research transplant is being tested in this Pilot study for the first time and is different from a standard transplant because: 1. Haploidentical donors will be used, and 2. A new combination of drugs that does not completely wipe out the bone marrow cells (non-myeloablative treatment) will be used to prepare the patient for transplant, and 3. Most of the donor CD4+ T cells (a type of immune cells) will removed (depleted) before giving the transplant to the patient. After non-myeloablative conditioning treatment and haploidentical transplant, some of the blood cells in the recipient (patient) will be from the donor (mixed chimerism). Having the right mix of donor to recipient T cells can help improve haploidentical transplant outcomes.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Nipent

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00038025 A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies Completed M.D. Anderson Cancer Center Phase 2 1994-09-01 The purpose of this study is to determine the side effects and antitumor response of patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.
NCT00131313 Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia. Unknown status Astex Pharmaceuticals Phase 4 2003-01-01 This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.
NCT00131313 Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia. Unknown status Mena, Raul, M.D. Phase 4 2003-01-01 This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.
NCT00131313 Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia. Unknown status Pharmatech Oncology Phase 4 2003-01-01 This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.
NCT00131313 Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia. Unknown status East Valley Hematology and Oncology Medical Group Phase 4 2003-01-01 This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nipent

Condition Name

Condition Name for Nipent
Intervention Trials
Lymphoma 2
Chronic Lymphocytic Leukemia 2
Sickle Cell Disease 2
Sickle Cell Disorder 1
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Condition MeSH

Condition MeSH for Nipent
Intervention Trials
Leukemia 3
Lymphoma 3
Leukemia, Lymphoid 3
Leukemia, Lymphocytic, Chronic, B-Cell 3
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Clinical Trial Locations for Nipent

Trials by Country

Trials by Country for Nipent
Location Trials
United States 38
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Trials by US State

Trials by US State for Nipent
Location Trials
Texas 4
Maryland 3
New York 2
Missouri 2
Indiana 2
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Clinical Trial Progress for Nipent

Clinical Trial Phase

Clinical Trial Phase for Nipent
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Nipent
Clinical Trial Phase Trials
Completed 3
Recruiting 2
Terminated 2
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Clinical Trial Sponsors for Nipent

Sponsor Name

Sponsor Name for Nipent
Sponsor Trials
Astex Pharmaceuticals 3
M.D. Anderson Cancer Center 2
Pharmatech 1
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Sponsor Type

Sponsor Type for Nipent
Sponsor Trials
Industry 7
Other 7
NIH 2
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